A footnote regarding Prozac/ Fluoxetine; it was noted
to commonly known cause infrequent Migraines from its administration.
In addition, it was also know to cause rarely cause vascular headaches
too, which in turn could trigger more Migraines. During clinical testing
in the United States, multiple doses of Prozac were administered to
approximately 5,600 subjects. Untoward events associated with this
exposure were recorded by clinical investigators using descriptive
terminology of their own choosing. Consequently, it is not possible
to provide a meaningful estimate of the proportion of individuals
experiencing adverse events without first grouping similar types of
untoward events into a limited (i.e., reduced) number of standardized
In the tabulations that follow, a standard COSTART
Dictionary terminology has been used to classify reported adverse
events. The frequencies presented, therefore, represent the proportion
of the 5,600 individuals exposed to Prozac who experienced an event
of the type cited on at least 1 occasion while receiving Prozac. All
reported events are included except those already listed in Table
1, those COSTART terms so general as to be uninformative, and those
events where a drug cause was remote. It is important to note that
this information was not presented to you to deter you from using
Prozac/ Fluoxetine, but rather point out it should be considered when
you and your doctor have excused other more appropriate preventive
regimes, particularly those regimes approved by the FDA like Depakote
family drug as an example. The follow events where noted.
Events are further classified within the body system
categories and enumerated in order of decreasing frequency using the
following definitions: frequent adverse events are defined as those
occurring on 1 or more occasions in at least 1/100 patients; infrequent
adverse events are those occurring in 1/100 to 1/1000 patients; rare
events are those occurring in less than 1/1000 patients.
Body as a Whole--Frequent: chills; Infrequent:
chills and fever, cyst, face edema, hangover effect, jaw pain, malaise,
neck pain, neck rigidity, and pelvic pain; Rare: abdomen enlarged,
cellulitis, hydrocephalus, hypothermia, LE syndrome, moniliasis, and
Cardiovascular System--Infrequent: angina pectoris,
arrhythmia, hemorrhage, hypertension, hypotension, Migraine,
postural hypotension, syncope, and tachycardia; Rare: AV block first
degree, bradycardia, bundle branch block, cerebral ischemia, myocardial
infarct, thrombophlebitis, vascular
headache, and ventricular arrhythmia.
Digestive System--Frequent: increased appetite;
Infrequent: aphthous stomatitis, dysphagia, eructation, esophagitis,
gastritis, gingivitis, glossitis, liver function tests abnormal, melena,
stomatitis, thirst; Rare: bloody diarrhea, cholecystitis, cholelithiasis,
colitis, duodenal ulcer, enteritis, fecal incontinence, hematemesis,
hepatitis, hepatomegaly, hyperchlorhydria, increased salivation, jaundice,
liver tenderness, mouth ulceration, salivary gland enlargement, stomach
ulcer, tongue discoloration, and tongue edema.
Endocrine System--Infrequent: hypothyroidism;
Rare: goiter and hyperthyroidism.
Hemic and Lymphatic System--Infrequent: anemia
and lymphadenopathy; Rare: bleeding time increased, blood dyscrasia,
leukopenia, lymphocytosis, petechia, purpura, sedimentation rate increased,
Metabolic and Nutritional--Frequent: weight
loss; Infrequent: generalized edema, hypoglycemia, peripheral edema,
and weight gain; Rare: dehydration, gout, hypercholesteremia, hyperlipemia,
hypoglycemic reaction, hypokalemia, hyponatremia, and iron deficiency
Musculoskeletal System--Infrequent: arthritis,
bone pain, bursitis, tenosynovitis, and twitching; Rare: bone necrosis,
chondrodystrophy, muscle hemorrhage, myositis, osteoporosis, pathological
fracture, and rheumatoid arthritis.
Nervous System--Frequent: abnormal dreams and
agitation; Infrequent: abnormal gait, acute brain syndrome, akathisia,
amnesia, apathy, ataxia, buccoglossal syndrome, CNS stimulation, convulsion,
delusions, depersonalization, emotional lability, euphoria, hallucinations,
hostility, hyperkinesia, hypesthesia, incoordination, libido increased,
manic reaction, neuralgia, neuropathy, paranoid reaction, psychosis,
and vertigo; Rare: abnormal electroenthesia, CNS depression, coma,
dysarthria, dystonia, extrapyramidal syndrome, hypertonia, hysteria,
myoclonus, nystagmus, paralysis, reflexes decreased, stupor, and torticollis.
Respiratory System--Frequent: bronchitis, rhinitis,
and yawn; Infrequent: asthma, epistaxis, hiccup, hyperventilation,
and pneumonia; Rare: apnea, hemoptysis, hypoxia, larynx edema, lung
edema, lung fibrosis/alveolitis, and pleural effusion.
Skin and Appendages--Infrequent: acne, alopecia,
contact dermititis, dry skin, herpes simplex, maculopapular rash,
and urticaria; Rare: eczema, erythema multiforme, fungal dermititis,
herpes zoster, hirsutism, psoriasis, purpuric rash, pustular rash,
seborrhea, skin discoloration, skin hypertrophy, subcutaneous nodule,
and vesiculobullous rash.
Special Senses--Infrequent: amblyopia, conjunctivitis,
ear pain, eye pain, mydriasis, photophobia, and tinnitus; Rare: blepharitis,
cataract, corneal lesion, deafness, diplopia, eye hemorrhage, glaucoma,
iritis, ptosis, strabismus, and taste loss.
Urogenital System--Infrequent: abnormal ejaculation,
amenorrhea, breast pain, cystitis, dysuria, fibrocystic breast, leukorrhea,
menopause, menorrhagia, ovarian disorder, urinary incontinence, urinary
retention, urinary urgency, urination impaired, and vaginitis; Rare:
abortion, albuminuria, breast enlargement, dyspareunia, epididymitis,
female lactation, hematuria, hypomenorrhea, kidney calculus, metrorrhagia,
orchitis, polyuria, pyelonephritis, pyuria, salpingitis, urethral
pain, urethritis, urinary tract disorder, urolithiasis, uterine hemorrhage,
uterine spasm, and vaginal hemorrhage.
If you are uncomfortable with using this medication
as a preventive sit down with your doctor, present this and other
concerns you may have. Then listen to your doctor and if you suffer
from a co-morbid condition such as clinical depression, then there
would be more merit to following this course.